CN105169505A - Method for sterilizing a hollow fibre filter module, hollow fibre filter module with closure and oxygen-absorbing closure - Google Patents
Method for sterilizing a hollow fibre filter module, hollow fibre filter module with closure and oxygen-absorbing closure Download PDFInfo
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- CN105169505A CN105169505A CN201510334010.3A CN201510334010A CN105169505A CN 105169505 A CN105169505 A CN 105169505A CN 201510334010 A CN201510334010 A CN 201510334010A CN 105169505 A CN105169505 A CN 105169505A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
- A61L2/081—Gamma radiation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/168—Sterilisation or cleaning before or after use
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M1/3403—Regulation parameters
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D65/00—Accessories or auxiliary operations, in general, for separation processes or apparatus using semi-permeable membranes
- B01D65/02—Membrane cleaning or sterilisation ; Membrane regeneration
- B01D65/022—Membrane sterilisation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/23—Containers, e.g. vials, bottles, syringes, mail
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2313/00—Details relating to membrane modules or apparatus
- B01D2313/02—Specific tightening or locking mechanisms
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2313/00—Details relating to membrane modules or apparatus
- B01D2313/21—Specific headers, end caps
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
- B01D63/02—Hollow fibre modules
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- Urology & Nephrology (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Emergency Medicine (AREA)
- External Artificial Organs (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
Methods of sterilizing a hollow fiber filter module, hollow fiber filter modules comprising closures and closures comprising an oxygen absorber are disclosed. A method according to the invention is distinguished in that the interior of the hollow fiber filter module is sealed off by means of the housing associated to the hollow fiber filter module and by means of the closures, and at least one of the closures comprises an oxygen absorber. A hollow fiber filter module according to the invention is characterized by the corresponding closures with or without an oxygen absorber.
Description
Technical field
The present invention relates to a kind of method according to claim 1 preamble, specifically, relating to a kind of method for carrying out doughnut filter module based on gamma-emitting sterilizing.
In addition, the present invention relates to a kind of hollow fiber filter module according to claim 5 preamble, specifically, relate to a kind of especially can be used on for the hollow fiber filter module in the dialysis apparatus of extracorporeal blood purification.Closure, also belong to theme of the present invention for the closing cock of seal ground closed hollow fabric filter module specifically.
Background technology
Hollow fiber filter module in the dialysis apparatus purified for extracorporeal blood, that have common existing structure or dialyser are made up of following substantially: be hollow fiber bundle on the one hand, blood to be cleaned is carried by described hollow fiber bundle; And be space on the other hand, described spatial loop is around the independent doughnut of hollow fiber bundle, and dialysis solution is carried by described space.At most of conditions, the flow direction of dialysis solution is contrary with the flow direction of blood.The wall of doughnut or doughnut is made up of semipermeable materials, and this allows water and any material be dissolved in wherein to exchange on the one hand, and prevents the exchange of hemocyte on the other hand.
For being known for hollow fiber filter module desired use in the medical field and to the various methods that doughnut filter module carries out sterilizing.
Such as, DE2716178A1 describes some methods, in each method, first hollow fiber filter module subject to sterilization being filled out is placed in parcel (wrapping), by means of sterilizing gas or by irradiation, sterilizing is carried out to parcel inner space, emptying subsequently and finally refill by controlled gaseous atmosphere.
If according in the method for DE2716178A1, sterilizing is carried out by means of gamma-radiation in inner space, so usually, must guarantee there is no oxygen near doughnut, because described oxygen can interact with hollow fiber material because of gamma-radiation or react, and the membrane property of doughnut will deterioration thus.Therefore, in order to avoid this deterioration of membrane property during the hollow fiber filter module sterilizing by means of irradiation, as described in EP0759873B1, be accustomed to collecting by means of Oxygen body the oxygen be encapsulated in together with hollow fiber filter module in parcel, and made described oxygen away from doughnut thus.
Various Oxygen body or tie substance and packaging are disclosed in such as US2001/0023232A1, EP0898508B1, EP0664824B1 and EP2009062B1.
The following fact is: hermetically sealed packaging needs expensive welding procedure according to the problem that the conventional implementation of the sterilizing methods of EP0759873B1 has, the volume encapsulated greatly can to change and therefore the capacity of Oxygen body has to be evaluated as unnecessarily large because packaging elasticity, and the workload of packing (this packaging meets all transports and storage condition) for the safety asepsis of hollow fiber filter module quite greatly.
Summary of the invention
Target of the present invention is the sterilizing works amount reducing hollow fiber filter module, thus meets the relevant requirement of identical or even higher safety.
This object reference has the sterilizing methods of the feature of claim 1 and realizes with reference to the hollow fiber filter module in independent claims and hollow fiber filter closure.
According to the theme that method of the present invention and the development favourable further according to equipment of the present invention are dependent claims.
Can use in the dialysis apparatus purified for extracorporeal blood and method according to the present invention carrys out the hollow fiber filter module of sterilizing by means of gamma-radiation or dialyser generally comprises shell, described shell has at least two the first ports leading to the first inner region and at least two the second ports leading to the second inner region.Described first port provides the first inner region of fresh dialysis fluid being introduced hollow fiber filter module during blood purification and discharges and anyly uses dialysis solution, and the described dialysis solution that used may containing the excessive water from blood to be cleaned.Second port provides introduces the second inner region by not clean blood and the clean blood of discharge.
The remarkable part of sterilizing methods according to the present invention is by the first inner region and the second inner region deadend, especially in mode that is airtight or air-tight manner deadend.Compared with hitherto known method, this is by means of packing realization in addition, but on the other hand to realize by means of closure by means of shell on the one hand.In this context, closure can when without being mounted to the corresponding ports of shell when any instrument and dismantling from described port, and in the assembled state, with rub and/or form fit mode to be connected to corresponding ports.For example, port closing cock or closing cover are closed, and described closing cock or closing cover coordinate by press-in or be connected to port to frictionally by means of screw thread.Also may carry out closed port with closure, described closure can in the form fit system (as by means of being fastened and connected) or coordinate in the form simultaneously and friction mode to be connected to port.In addition, in order to closed port at least one times, use and comprise the closure of the Oxygen body with reaction surface region, described Oxygen body is received by described reaction surface region or absorbs the oxygen encapsulated in the first inner region and/or the second inner region.Oxygen body preferably comprises the iron powder containing water of crystallization to implement to absorb process.As long as meet the requirement about the medical science suitability, also other compositions can be dreamed up.The uncombined oxygen point rate that Oxygen body allow in the first inner region and/or the second inner region reduces in a large number, thus makes it possible to carry out harmless sterilizing by gamma-radiation to doughnut filter module.
In the method according to the invention, advantageously, use and when allowing to save other packaging without any the independent closure installed when instrument, and can therefore save corresponding required packaging facilities or packer.Shell due to hollow fiber filter module is used as sterile barrier (and not usually flexible package foil), and this is true, therefore can not only save the workload of the compactness guaranteeing package foil and storage and Transport Safety, and the capacity of Oxygen body mates with the internal capacity of the more stable shell of hollow fiber filter module with may correspond to more accurately.
Due to the first inner region and the second inner region separated from one another by semipermeable membrane, therefore interval in two oxygen exchange is possible, but may need time of more growing.Therefore, according to a further aspect in the invention, if every Single port of the first port and the second port is closed by the closure comprising Oxygen body, then this is favourable.Therefore, not only make oxygen may must flow via semipermeable membrane or spread to arrive Oxygen body becoming unnecessary, and make the capacity adaptation of at least two Oxygen bodies in the corresponding volume of the first inner region and/or the second inner region.
According to a further aspect in the invention, the first inner region and/or the second inner region can rinse with protective gas before closed first inner region and/or the second inner region.Favourable like this, because this measure decreases the amount of the encapsulated oxygen absorbed by means of Oxygen body of having to.
In addition, if to increase with the volume of the Oxygen body of oxygen reaction for the reaction surface region and considering of Oxygen body, then this can be favourable.Therefore, the remarkable part of Oxygen body according to the present invention can be: the reaction surface region of Oxygen body is without any undercut portions (undercut), described undercut portions increases and undue growth along with the volume with absorbed oxygen reaction, thus the part making undercut portions in fact can receive oxygen is isolated with oxygen.
A kind of hollow fiber filter module that can use in the dialysis apparatus purified for extracorporeal blood according to the present invention comprises: shell, described shell have lead to the first inner region with supply and discharge dialysis solution at least two the first ports and lead to the second inner region with supply and discharge blood at least two the second ports.
Property feature according to hollow fiber filter module of the present invention is that it comprises closure, described closure separately can when without any being mounted to a port of shell when instrument and dismantling from described port, and can rub and/or form fit system to be connected to corresponding port.Closure allows by means of shell by the first inner region and the second inner region deadend, especially with airtight or air-tight manner deadend, and does not need other packaging or parcel.In order to reduce the amount of the uncombined oxygen encapsulated in the first inner region and/or the second inner region, and prevent the adverse effect of the doughnut of uncombined oxygen and hollow fiber filter module thus during by gamma-radiation sterilizing, at least one of described closure comprises Oxygen body, described Oxygen body comprises reaction surface region, and any oxygen encapsulated in the first inner region and/or the second inner region all receives at least in part by described reaction surface region, collect or absorbs.
Closure can when need not be mounted to the corresponding ports of shell and dismantle from described port when any instrument, and in the assembled state, with rub and/or form fit system to be connected to corresponding ports.For example, closure is implemented by closing cock, closing cover or closing cap, and described closing cock, closing cover or closing cap coordinate by press-in or be connected to port to frictionally by means of screw thread.Also may give closure so a kind of design: described closure can in the form fit system (as by means of being fastened and connected) or coordinate in the form simultaneously and friction mode to be connected to port.
Oxygen body preferably comprises the iron powder containing water of crystallization to realize absorbing process.As long as meet the requirement about the medical science suitability, also other compositions can be dreamed up.
Advantageously, for the closure of the first port be equipped with Oxygen body for each in the closure of the second port.Therefore, the first inner region and the second inner region can have the direct path leading to Oxygen body described in one of them separately, thus allow to reduce until the amount of the oxygen absorbed enough large required waiting time.
In order to ensure the safety of closure and/or the manipulation of more ergonomics, if be provided with the external shape of the closure of Oxygen body and/or outward appearance to be different from external shape without the closure of Oxygen body and/or outward appearance, then this can be favourable.In this context, term " external shape and/or outward appearance " refers in particular to those parts that closure can be accessed from outside by people, even when closure is mounted to hollow fiber filter module of the present invention.Subsequently, this type of different closure can be distinguished with vision and/or tactile manner by the staff of responsible hollow fiber filter module.
As illustrated in the description of method according to the present invention, if to increase with the volume of the Oxygen body of oxygen reaction for the reaction surface region and considering of Oxygen body, then this can be favourable.Therefore, the remarkable part of Oxygen body according to the present invention can be: the reaction surface region of Oxygen body is without any undercut portions, described undercut portions increases and undue growth along with the volume with absorbed oxygen reaction, thus the part making undercut portions in fact can receive oxygen is isolated with oxygen.
Hollow fiber filter module can be mounted to when not using instrument according to closure of the present invention, especially according at least one port of hollow fiber filter module of the present invention with dismantle from described port, and corresponding ports can be connected to friction and/or form fit system.Closure allows at least one port deadend, especially with airtight or air-tight manner deadend.
Be Oxygen body according to the property feature of closure of the present invention, described Oxygen body is arranged in closure, and the reaction surface region of described Oxygen body can absorb any uncombined oxygen encapsulated in the first inner region and/or the second inner region at least in part.Therefore, Oxygen body is arranged in closure as follows: on the one hand, described Oxygen body is connected with the first inner region to be closed and/or the second inner region fluid, and on the other hand, described Oxygen body is sealed with isolated outside atmosphere by the part of closure relative to the first inner region and/or the second inner region.
Described Oxygen body preferably comprises iron powder and water of crystallization.
Advantageously, reaction surface region can be designed so that described reaction surface region does not have undercut portions, described undercut portions, after the volume of described Oxygen body increases because of the reaction with absorbed oxygen, is isolated making the part in described reaction surface region with the still unabsorbed any oxygen in the first inner region and/or the second inner region.
Accompanying drawing explanation
The present invention is describe in further detail by preferred illustrative embodiments below with reference to signal accompanying drawing, wherein:
Fig. 1 be sterilizing in order to carry out according to prior art and be encapsulated in the sectional view of the hollow fiber filter module in packaging together with independent Oxygen body;
Fig. 2 is according to the sectional view being equivalent to the hollow fiber filter module of Fig. 1 of the present invention;
Fig. 3 a is according to the sectional view comprising the closure of Oxygen body of the present invention; And
Fig. 3 b is the top view of the closure shown in Fig. 3 a.
Detailed description of the invention
General hollow fiber filter module 2 comprises shell 4 as shown in Figure 1, and described shell 4 can be subdivided into: lid shape blood entry port section 4a; Hollow fiber bundle section 4b-d; Substantially cylindricality, especially columniform dialysis solution section 4e; And same lid shape blood exit zone 4f.
Hollow fiber bundle section 4b-d and then be formed by following: the first, especially circular hollow fiber bundle keeper 4b, described hollow fiber bundle keeper 4b embeds the end of doughnut 4c; Hollow fiber bundle, described hollow fiber bundle is made up of the doughnut 4c be arranged parallel to each other; And the hollow fiber bundle keeper 4d of second, especially circle, described hollow fiber bundle keeper 4d embeds another end of doughnut 4c.Therefore, hollow fiber filter module 2 is by being poured in end sealing, installed by the compound of sealing, and optionally carry out cutting two ends after encapsulation process to make any doughnut 4c closed by encapsulation process unintentionally access again.
The dialysis solution section 4e of shell 4 extends around the space of the hollow fiber bundle section 4b-d be limited between two hollow fiber bundle keeper 4b and 4d, and described dialysis solution section 4e especially has the shape of cylindrical housings.Between doughnut 4c by two hollow fiber bundle keeper 4b and 4c and shell 4 dialysis solution section 4e the space closed correspond to the first inner region 10 of hollow fiber filter module 2.
The lid shape blood entry port section 4a of shell 4 arranges or is attached on first hollow fiber bundle keeper 4b that side away from hollow fiber bundle section 4e, makes to limit blood distribution space between blood entry port section 4a and the first hollow fiber bundle keeper 4b.
The lid shape blood exit zone 4f of shell 4 arranges or is attached on second hollow fiber bundle keeper 4d that side away from hollow fiber bundle section 4e, makes to limit blood collecting space between blood exit zone 4f and the second hollow fiber bundle keeper 4d.
Space in the blood distribution space combined, doughnut 4c and blood collecting space correspond to the second inner region 16 of hollow fiber filter module 2.
Port one 2 for supplying blood is provided in the blood entry port section 4a of shell 4, port one 4 for discharging blood is provided in the blood exit zone 4f of shell 4, and on the dialysis solution section 4e of shell 4, dialysis solution entrance 6 is provided near the second hollow fiber bundle keeper 4d, and dialysis solution outlet 8 is provided near the first hollow fiber bundle keeper 4b.
As described in Figure 1, be fill out together with the Oxygen body 26 be separated to be put in the special bag shape be made of plastics and to pack in V before carrying out sterilizing by means of gamma-radiation according to the general hollow fiber filter module 2 of prior art.In order to sealed package V is with impermeable gas, open end is sealed by weld seam S.
By contrast, Fig. 2 illustrates the sectional view according to hollow fiber filter module of the present invention and Fig. 1 equivalence.Compared with conventional hollow fiber filter module, hollow fiber filter module 2 according to the present invention comprises the closure 18,20,22 and 24 in closing cock form, described closure can, when without being connected to port 6,8,12 and 14 when any instrument, make the first inner region 10 and the second inner region 16 be closed with impermeable gas.
As passed through shown in closure 20 example in Fig. 3 a and Fig. 3 b, closure 18,20,22 and 24 is respectively made up of following naturally: cylindrical enclosure 28, and described cylindrical enclosure has the outer wall being provided with thin plate 30 in circumferential direction; And manipulation part 32.For closure 20, the implementation method that sealing has the corresponding ports 8 of circular cylindrical shell shape is: in manipulation, part 32 place grasps closure 20, and the cylindrical enclosure 28 of closure 20 is moved to port 8, cylindrical enclosure 28 is inserted in port 8 (having cylindrical shell shape) by press-in cooperation.According to an embodiment, the design that press-in fits through the elastically deformable of whole closure 20 is established.Make thin plate 30 or only closure member 28 realize the embodiment of elastically deformable also in implication of the present invention.Not only closure 18,20,22 and/or 24 but also corresponding ports 6,8,12 and/or 14 are all designed to any embodiment of completely or partially elastically deformable also within the scope of the present invention.
At this, term " design of elastically deformable " refers to that the shape of closure 20 and/or port 8 is by manually applying compression stress to change, make closure member 20a to be inserted in corresponding ports 8, and when complete apply compression stress to closure 20 and/or port 8, the shape of closure 20 and/or port 8 is recovered again, the cylindricality exterior contour making closure member 28 or closure member 28 at least partly against the cylindrical internal profile of port 8 or port 8 and closed port 8 with impermeable gas.Elasticity by suitable selection material and/or can determine that suitable physical dimension realizes.
Closure 20 comprise be positioned on closure member 28, be that closure member 28 faces the Oxygen body 26 on corresponding that side of inner region 10 when closure 20 is installed in hollow fiber filter module 2 or rather.Oxygen body 26 is realized by the loose structure containing iron powder and water of crystallization.The size of the size of Oxygen body 26 is configured to corresponding inner region 10 and 16 proportional.
Closure member 28 is circular sleeve shape housings substantially, and described closure member 28 has the circular interior being furnished with circular piston shape Oxygen body 26.Oxygen body 26 is to be frictionally coupled to closure member 28 by means of press-in cooperation; To substitute or additionally, described Oxygen body 26 also can be cast, original position gummed or be connected by form and combine.The exterior cylindrical surface of closure member 28 can cooperate with the corresponding inner cylindrical surface of port 8, and corresponds to sealing surfaces thus.Circumference thin plate 30 provides for improving sealing characteristics.
Circular sleeve shape closure member 28 is designed to open wide to side Oxygen body 26 is connected with the surrounding ambient fluid of closure 20.If closure 20 is attached to hollow fiber filter module 2, these surroundings then correspond to the first inner region or second inner region 10 of hollow fiber filter module 2.In addition, film (attached not shown) can be provided in sleeve-shaped closure member 28 open side, thus guarantee that any oxygen can arrive Oxygen body 26 on the one hand, and it is inner to guarantee that the part departing from from Oxygen body 26 or be separated does not leave closure member 28 on the other hand, so that the potential risk of the corresponding inner region 10 of preventing pollution hollow fiber filter module 2.
The opposite side of circular sleeve shape closure member 28 is divided by the plate portion of Rotational Symmetry manipulation part 32 to adjoin with one heart.The plate portion of manipulation part 32 is divided and is formed single-piece with closure member 28.Or the plate portion of manipulation part 32 is divided and closure member 28 also can have more than one piece design.The plate portion of manipulation part 32 is divided and is adjoined closure member 28, makes the inside of the closure member 28 being furnished with oxygen inhaler 26 correspond to blind hole.
The edge of circular sleeve shape edge or cylindrical hull shape is arranged essentially parallel to closure member 28 at the plate shape Rotational Symmetry part edge place of manipulation part 32 and extends.Manipulation part 32 edge makes the circumference of described manipulation part 32 be provided with the grip part of the depression of promotion grasping and manipulation closure 20.The edge placement of manipulation part 32 is divided in the plate portion of manipulation part 32, if make closure member 28 insert in the tubular portion of port 8, the tubular portion of the port 8 that plate portion is divided described in so described surrounded by edges, just as crown cap (crowncap).At this, the inner surface at manipulation part 32 edge can abut against the outer surface of port 8 tubular portion, and thus as a part for sealing surfaces.But, also may keep annular gap between the inner surface at manipulation part 32 edge and the outer surface of port 8 tubular portion.The inner surface at manipulation part 32 edge is shaped as conical a little; Or it also can be cylindrical.
As shown in Figure 1, port 6,8,12 and 14 and therefore corresponding (not shown) closure 18,20,22 and 24 all can have formed objects.According to the embodiment shown in Fig. 2, also only the closure 18 and 20 of the first port 6 and 8 and correspondence or the closure 22 and 24 of the second port one 2 and 14 and correspondence formed objects may be had.
In order to can distinguish and identify generally the closure 20 and 22 that is provided with Oxygen body 26 with even in the assembled state also without the same large closure 18 and 24 of Oxygen body 26, if closure 20 or 22 is mounted to hollow fiber filter module 2, so provide the labelling 34 of recess form in the form of a ring away from that side of corresponding inner region 10 or 16 at the manipulation part 32 of closure 20 and 22.As substituting this labelling, any different embossment and/or additional graphical information can be used to improve and to comprise the closure 20 and 22 of Oxygen body 26 and the resolvability between the same large closure 18 and 24 without Oxygen body.
Closure 20 and 22 is made up of polypropylene with injection moulding method.Or they also can be made up of polyformaldehyde, polyether-ether-ketone, polysulfones or other suitable plastic any.
Described above according to hollow fiber filter module 2 of the present invention and the possible implementation that represent just claimed invention according to the embodiment of closure 20 or 22 of the present invention shown in Fig. 2 to Fig. 3 b.
For example, closure 18,20,22 and 24 can also be shaped to cover shape mode, make to there is not the closure member 28 inserted in corresponding ports 6,8,12 or 14, but port 6,8,12 or 14 is received in the corresponding blind hole in closure 18,20,22 or 24 separately.
In order to closure 18,20,22 and 24 is not connected to corresponding ports 6,8,12 and 14 by means of only frictional fit and by interlock fit in either case, inside cylindricality shelly port 6,8,12 and 14, the recess that can receive thin plate 30 can be provided with.
Claims (10)
1. one kind for carrying out the method based on gamma-emitting sterilizing to doughnut filter module (2), the shell (4) of described hollow fiber filter module (2) has and leads to the first inner region (10) to supply and discharge at least two first ports (6,8) of dialysis solution and lead to the second inner region (16) to supply and to discharge at least two second ports (12,14) of blood
It is characterized in that,
Described first inner region (10) and described second inner region (16) are by means of described shell (4) and carry out deadend by means of closure (18,20,22,24), especially with airtight or air-tight manner deadend, described closure (18,20,22,24) all can be mounted in the described port (6,8,12,14) of described shell (4) and remove from described port when not using any instrument, and can be connected to corresponding port (6,8,12,14) with friction and/or form lock mode; And
Described closure (20,22) at least one in comprises Oxygen body (26), described Oxygen body (26) has reaction surface region, and described reaction surface region at least in part, preferably fully absorbs any oxygen of described first inner region (10) and/or the middle encapsulating of described second inner region (16).
2. method according to claim 1, it is characterized in that, one (12) in one (8) in described first port (6,8) and described second port (12,14) are closed by the closure (20,22) comprising Oxygen body (26).
3. method according to claim 1 and 2; it is characterized in that; before described first inner region (10) and/or described second inner region (16) being closed, rinse described first inner region (10) and/or described second inner region (16) with protective gas.
4. according to the method in any one of claims 1 to 3, it is characterized in that, the described reaction surface region of described Oxygen body (26) is without any undercut portions, described undercut portions, after described Oxygen body (26) volume increases because of the reaction with absorbed oxygen, to be encapsulated making in the part in described reaction surface region and described first inner region (10) and/or described second inner region (16) and still unabsorbed any oxygen is isolated.
5. a hollow fiber filter module (2), described hollow fiber filter module (2) can use in the dialysis apparatus purified for extracorporeal blood, and comprise shell (4), described shell (4) comprises and leads to the first inner region (10) to supply and discharge at least two first ports (6,8) of dialysis solution and lead to the second inner region (16) to supply and to discharge at least two second ports (12,14) of blood
It is characterized in that,
Described hollow fiber filter module (2) comprises closure (18,20,22,24), described closure (18,20,22,24) all can be mounted in the described port (6,8,12,14) of described shell (4) and remove from described port when not using any instrument, and can be connected to described corresponding port (6,8,12,14) with friction and/or form lock mode;
Described first inner region (10) and/or described second inner region (16) can by means of described shell (4) and described closure (18,20,22,24) deadends, especially with airtight or air-tight manner deadend; And
At least one in described closure (20,22) comprises Oxygen body (26), described Oxygen body (26) has reaction surface region, and described reaction surface region can absorb any oxygen of encapsulating in described first inner region (10) and/or described second inner region (16).
6. hollow fiber filter module (2) according to claim 5, it is characterized in that, be provided with Oxygen body (26) at least one (20) in described first closure (18,20) of described first port with at least one (22) in the described closure (22,24) of described second port.
7. the hollow fiber filter module (2) according to claim 5 or 6, is characterized in that,
The described closure (20,22) being provided with Oxygen body and the described closure (18,24) without Oxygen body in their external shape and/or different in appearance, to make them can from outside with vision and/or tactile manner differentiation when being mounted to described hollow fiber filter module (2); And/or
Described closure (18,20) for described first port and the external shape and/or in appearance different of the described closure (22,24) for described second port at them, its mode can be distinguished from outside with vision and/or tactile manner when being mounted to described hollow fiber filter module (2) for making them.
8. the hollow fiber filter module (2) according to any one of claim 5 to 7, it is characterized in that, the described reaction surface region of described Oxygen body (26) is without any undercut portions, described undercut portions, after described Oxygen body (26) volume increases because of the reaction with absorbed oxygen, is isolated making the part in described reaction surface region with the still unabsorbed any oxygen in described first inner region (10) and/or described second inner region (16).
9. the closure (20 for the hollow fiber filter module (2) especially according to any one of claim 5 to 8, 22), described closure (20, 22) at least one port (8 of described hollow fiber filter module (2) can be mounted to when not using any instrument, 12) and from described port dismantle, and corresponding port (8 can be connected to friction and/or form lock mode, 12), and described port (8, 12) at least one in can carry out deadend by means of described closure, especially with airtight or air-tight manner deadend, it is characterized in that,
Described closure comprises Oxygen body (26), described Oxygen body (26) has reaction surface region, and any oxygen of the first inner region (10) and/or the middle encapsulating of the second inner region (16) fully can be absorbed at least in part, preferably by means of described reaction surface region.
10. closure according to claim 9 (20,22), it is characterized in that, the described reaction surface region of described Oxygen body (26) is without any undercut portions, described undercut portions, after described Oxygen body (26) volume increases because of the reaction with absorbed oxygen, is isolated making the part in described reaction surface region with the still unabsorbed any oxygen in described first inner region (10) and/or described second inner region (16).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102014108530.2 | 2014-06-17 | ||
| DE102014108530.2A DE102014108530A1 (en) | 2014-06-17 | 2014-06-17 | Method for sterilizing a hollow fiber filter module, hollow fiber filter module with closure and oxygen absorbing closure |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105169505A true CN105169505A (en) | 2015-12-23 |
Family
ID=53396233
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510334010.3A Pending CN105169505A (en) | 2014-06-17 | 2015-06-16 | Method for sterilizing a hollow fibre filter module, hollow fibre filter module with closure and oxygen-absorbing closure |
| CN201520417523.6U Active CN205055007U (en) | 2014-06-17 | 2015-06-16 | Hollow fiber filter module and oxygen uptake seal |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201520417523.6U Active CN205055007U (en) | 2014-06-17 | 2015-06-16 | Hollow fiber filter module and oxygen uptake seal |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US20150359958A1 (en) |
| EP (1) | EP2965767B1 (en) |
| JP (1) | JP2016002466A (en) |
| CN (2) | CN105169505A (en) |
| BR (1) | BR102015014052A2 (en) |
| DE (1) | DE102014108530A1 (en) |
| RU (1) | RU2015122393A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107839926A (en) * | 2016-09-19 | 2018-03-27 | B·布莱恩·阿维图姆股份公司 | Including the sterile chamber of sterile barrier separated with primary package and the method for manufacturing sterile chamber |
| CN109477652A (en) * | 2016-07-22 | 2019-03-15 | 三菱电机株式会社 | Air cleaning unit and dust-collecting filter |
| CN112245691A (en) * | 2019-07-22 | 2021-01-22 | 巴克斯特医疗保健股份有限公司 | Method and system for preparing dialysate from raw water |
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| DE102014108530A1 (en) * | 2014-06-17 | 2015-12-17 | B. Braun Avitum Ag | Method for sterilizing a hollow fiber filter module, hollow fiber filter module with closure and oxygen absorbing closure |
| DE102016102087A1 (en) * | 2016-02-05 | 2017-08-10 | B. Braun Avitum Ag | Filter module Packing unit |
| DE102016102084A1 (en) * | 2016-02-05 | 2017-08-10 | B. Braun Avitum Ag | Filter module Packing unit |
| CN107469170A (en) * | 2017-09-29 | 2017-12-15 | 成都威力生生物科技有限公司 | A kind of wearable artificial kidney |
| DE102018201030A1 (en) | 2018-01-24 | 2019-07-25 | Kardion Gmbh | Magnetic coupling element with magnetic bearing function |
| DE102018208536A1 (en) * | 2018-05-30 | 2019-12-05 | Kardion Gmbh | A lead apparatus for directing blood flow to a cardiac assist system, method of making a lead apparatus, and method of assembling a cardiac assist system |
| DE102018211327A1 (en) | 2018-07-10 | 2020-01-16 | Kardion Gmbh | Impeller for an implantable vascular support system |
| JP6615969B1 (en) | 2018-09-26 | 2019-12-04 | 日東電工株式会社 | Hollow fiber membrane module |
| DE102020102474A1 (en) | 2020-01-31 | 2021-08-05 | Kardion Gmbh | Pump for conveying a fluid and method for manufacturing a pump |
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Also Published As
| Publication number | Publication date |
|---|---|
| EP2965767A2 (en) | 2016-01-13 |
| RU2015122393A (en) | 2017-01-10 |
| JP2016002466A (en) | 2016-01-12 |
| US20150359958A1 (en) | 2015-12-17 |
| DE102014108530A1 (en) | 2015-12-17 |
| CN205055007U (en) | 2016-03-02 |
| EP2965767B1 (en) | 2019-10-23 |
| BR102015014052A2 (en) | 2015-12-22 |
| EP2965767A3 (en) | 2016-05-25 |
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Application publication date: 20151223 |